Kornimate/medical-research-clean huggingface dataset:
ipilimumab 60-month pharmacovigilance protocol for advanced melanoma patients who are hepatitis b and/or hepatitis c virus positive in taiwan

Conditions: Advanced Melanoma; Hepatitis B; Hepatitis C

Summary: this protocol is being conducted to comply with the direct request from the taiwan food and drug administration (tfda) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis b (hbv) or hepatitis c (hcv) infection, regardless of control on antiviral therapy in taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) melanoma.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * age of 18 years or older on date of first dose of ipilimumab * patients who received at least 1 dose of ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in taiwan * patients with advanced melanoma and hbv or hcv who are initiating ipilimumab under the discretion of their physician exclusion criteria: * patients who received ipilimumab as part of a clinical trial * patients who are receiving ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma) * patients who are not infected with hbv or hcv

Keywords: hbv hbc
marginprobe® system u.s. post-approval study

Conditions: Breast Cancer

Summary: the study objective is to determine the marginprobe® system's diagnostic accuracy at the margin level and impact on positive margin\* presence originating from the main ex-vivo lumpectomy specimen after the initial lumpectomy surgery. \*a positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface

this is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be randomized to either standard of care with additional inspection ('soc + additional inspection' arm) or standard of care with marginprobe as an adjunct ('soc + device' arm). the marginprobe is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. it will be used by the surgeon during lumpectomy procedures only in patients randomized to the "device+soc" arm. randomization will take place following the excision of the main ex-vivo lumpectomy specimen.

Eligibility criteria:
inclusion criteria: * women histologically diagnosed with carcinoma of the breast * women with non-palpable malignant lesions, requiring image guided localization. * undergoing lumpectomy (partial mastectomy) procedure * age 18 years or more * signed icf exclusion criteria: * multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast) * bilateral disease (diagnosed cancer in both breasts) * neo-adjuvant systemic therapy * previous radiation in the operated breast * prior surgery in the same site in the breast * woman histologically diagnosed by an open biopsy procedure * implants in the operated breast * pregnancy * lactation * participating in any other investigational study for either drug or device which could influence collection of valid data under this study * patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)
safety and efficacy study of nvr 3-778 in healthy volunteers and hepatitis b patients

Conditions: Chronic Hepatitis B

Summary: this phase 1 trial will assess the dose-related safety and pk profile of different doses of nvr 3-778, first in healthy volunteer subjects (part i) and subsequently in patients with chronic hepatitis b (part ii). additionally, in part ii, changes in patients' serum hbv dna levels and other virologic efficacy parameters will be assessed.

the part i (phase 1a) assessments of the dose-related safety and pk of nvr 3-778 in volunteers will be conducted an established phase 1 unit, which will facilitate the overnight confinements and frequent safety assessments and blood sampling required for the part i evaluations. the part ii (phase 1b) assessments of the dose-related safety, pk, and initial antiviral efficacy of nvr 3-778 in hepatitis b patients will also be conducted at approximately 14 different sites to meet enrollment goals of 54-84 chronic hepatitis b patients. to promote objective safety and tolerance assessments during this trial, study subjects, and site personnel administering the study drug and performing the clinical assessments on the subjects, will be blinded to individual subjects' treatments assignments (active nvr 3-778 or placebo doses), for all treatment cohorts in the study. study advancement to subsequent volunteer cohorts in part i and subsequent patient cohorts in part ii will require satisfactory interim reviews of available cumulative safety data by the part i and part ii safety review committees (srcs), using the safety criteria and review procedures described in the protocol. also, there will be two interim reviews of safety data by an independent safety monitoring board (smb), as described in the protocol.

Eligibility criteria:
healthy volunteers may be male or female between 18 and 65 years old with a bmi of 18-32kg/m2. they must be in good health not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study. patients enrolling in part ii of the study, may be male or female between 18 and 65 years of age, with a bmi of 18-35kg/m2. patients must have hbeag positive, chronic hepatitis b with no history of clinical decompensation, and must not have been treated for hepatitis b before.

Keywords: hepatitis b
efficacy and safety study of teneligliptin (mp-513) in combination with insulin in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of teneligliptin in combination with insulin in patients with type 2 diabetes for 16 weeks administration and to evaluate the safety and efficacy of teneligliptin in combination with insulin with an extension treatment for up to 52 weeks.


Eligibility criteria:
inclusion criteria: * patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug * patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * patients whose hba1c is between 7.5% and 10.5% * patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug. exclusion criteria: * patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc) * patients who are accepting treatments of arrhythmias * patients with serious diabetic complications * patients who are the excessive alcohol addicts * patients with severe hepatic disorder or severe renal disorder. * patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Keywords: insulin resistance
low-dose hormone therapy for relief of vasomotor symptoms

Conditions: Vasomotor Symptoms; Hot Flashes

Summary: the purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

this study has previously been posted by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc. bayer healthcare pharmaceuticals, inc. is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: - postmenopausal women \>40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week exclusion criteria: * the usual exclusion criteria for hormone therapy apply * intake of medications other than hormones affecting hot flushes

Keywords: vasomotor symptom relief postmenopausal women severe to moderate vasomotor symptoms
airway management for trigeminal thermal coagulation

Conditions: Airway Management

Summary: airway management of patients undergoing thermal coagulation of the gasserian ganglion is very delicate. this is because of the specific operation site and moreover patients should recover quickly from anesthesia to follow verbal intraoperative commands of the surgeon. endotracheal intubation or laryngeal mask of course hinders the patient from speaking. an obvious alternative airway management, as performed in this preliminary study, is a nasopharyngeal placed tube. the purpose of the present study is to objectify the gas exchange in patients during this new ventilation technique.


Eligibility criteria:
inclusion criteria: - patients undergoing thermal coagulation of the gasserian ganglion exclusion criteria: * body weight over 100 kg * recurrent nasal bleeding * patients suffering from reflux disease * additional risk of aspiration (e.g. hernia diaphragmalis)

Keywords: nasopharyngeal tube airway management thermal coagulation of the gasserian ganglion
effects of mesna on homocysteine in kidney failure

Conditions: End Stage Renal Disease

Summary: the purpose of this research study is to examine the effect of a drug called mesna on the removal of homocysteine from blood during dialysis. homocysteine is an amino acid (protein building block) found in the blood of all people, however it is considerably elevated in dialysis patients. people with increased levels of homocysteine in their blood are at increased risk of developing plaque buildup in their arteries and other related problems such as heart attack and stroke. this study will determine if mesna can improve the rate of homocysteine removal from blood during dialysis.

homocysteine is a thiol amino acid derived from dietary methionine. elevated plasma total homocysteine (thcy), termed hyperhomocysteinemia, is a graded, independent risk factor for the development of atherosclerosis. elevated plasma thcy can be normalized by supplementation with folic acid and vitamins b6 and b12 in most patients with normal renal function and this treatment has been shown to halt the progression of atherosclerotic plaque. over 90% of patients with end-stage renal disease (esrd) requiring hemodialysis have elevated plasma thcy. the leading causes of morbidity and mortality in these patients are cardiovascular-related pathologies such as myocardial infarction and stroke. vitamin supplementation consistently fails to normalize elevated plasma thcy in patients with esrd, thus leaving them at increased risk. plasma thcy is 70 - 80% covalently protein bound limiting the effectiveness of dialysis as a thcy lowering treatment. mesna (sodium 2-mercaptoethanesulfonic acid) is a thiol-containing drug currently indicated to prevent hemorrhagic cystitis associated with ifosfamide chemotherapy. mesna has incidentally been shown to deplete plasma thiols in cancer patients undergoing ifosfamide chemotherapy. mesna acts to exchange with thiols bound to plasma proteins enhancing their renal excretion. in vitro studies in our laboratory have shown that mesna rapidly (within 5 minutes) exchanges with protein bound homocysteine yielding a significantly larger dialyzable fraction of the thiol amino acid. a pilot study recently completed by our group demonstrated a significant decrease in thcy in eight hemodialysis patients receiving 12 mg/kg mesna three times a week pre-dialysis for one week. although this therapy did cause a significant decline in thcy, mesna failed to reduce thcy to normal levels. the cumulative effects of mesna administration over a longer treatment period should be evaluated.

Eligibility criteria:
inclusion criteria: * patients with end-stage renal disease who have received hemodialysis thrice weekly for at least 90 days * serum albumin \> 30 g/l. exclusion criteria: * patients who refuse to sign a letter of informed consent * women who are or are trying to become pregnant or are breast-feeding.

Keywords: homocysteine hemodialysis mesna
reducing mental health disparities among latinxs with a telenovela intervention

Conditions: Anxiety Disorders

Summary: the primary aim of our study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with spanish-speaking latinxs.

telenovela video interventions are a low-resource, low-cost methodology developed to diminish the treatment-provider gap (heilemann et al., 2017). research shows that telenovela interventions represent an acceptable (heilemann et al., 2018) and potent (heilemann et al., 2017) intervention option for disseminating information to the latinx population. prior research utilizing transmedia telenovela interventions that include a telenovela component have demonstrated some effectiveness at reducing symptoms of anxiety and depression among latinxs (heilemann et al., 2017; kajiyama et al., 2018) as have fotonovelas (sanchez et al., 2019). to date researchers have not investigated how the telenovela approach combined with a transdiagnostic treatment paradigm might help reduce behavioral health disparities among spanish-speaking latinxs given that such an intervention would be easily disseminable and target the two most common disorders observed among this population. the primary aim of this study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with spanish-speaking latinxs.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. identify as latinx 3. prefer behavioral health services in spanish 4. meet the dsm criteria for any mild to moderate anxiety disorder 5. ownership of a smartphone exclusion criteria: 1. suicidality 2. psychosis 3. bipolar disorder 4. severe anxiety disorders 5. severe depressive disorders 6. homicidality

Keywords: anxiety disorder transdiagnostic treatment united protocol
effects of dohsa hou exercises on functional mobility

Conditions: Down Syndrome

Summary: trisomy 21 is a condition where there's an extra chromosome 21, which leads to a set of clinical signs called down syndrome. down syndrome is one of the most complicated genetic conditions that can occur post-term and is the most commonly survivable form of aneuploidy of the autosomal chromosomes. dohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience. it was first developed under the name psycho-rehabilitation to help children with cerebral palsy improve their movements and posture. by using dohsa hou movement's issues were effectively addressed in children with cerebral palsy, despite their physical limitations being caused by physiological disorders. there are two kind of treatments of dohsa hou exercises that are relaxation therapy to decrease the stress level in body and other one is to align the body to correct the posture and movements of the body.

this study will be a randomized control trial, used to compare the effects of dohsa hou exercises on functional mobility in children with down syndrome. subjects with down syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling techniques. assessment will be done by using test of trunk impairment scale and time up and go test. subjects in one group will be treated with dohsa hou therapy and in other group standard treatment protocol.

Eligibility criteria:
inclusion criteria: 1. down syndrome 2. age group of 6 to 12 years old 3. male and female (both genders) 4. body mass index (bmi) within normal range \<95% 5. absence of any psychiatric and physical illness at the time of participation. exclusion criteria: 1. uncontrolled seizures 2. any kind of autoimmune diseases 3. registered visually impaired or hearing issues 4. severe atlanto axial instability 5. congenital heart defects (chd) 6. unable or unwilling to understand the commands

Keywords: dohsa hou exercise down syndrome psychomotor therapy
instillation of botox in the bladder in women with overactive bladder (oab)

Conditions: Overactive Bladder

Summary: instillation treatment with onabotulinumtoxin a (botox®) in the urinary bladder

pilot study to evaluate the effect of instillation treatment with onabotulinumtoxin a (botox®) in the urinary bladder using electromotive drug application (emda) in women with overactive bladder. 15 women with therapy-resistant oab will be included. all patients must be qualified for conventional cystoscopic botox injection. the study is not randomized or blinded. follow-up time is six months with voiding charts and three questionnaires (urinary distress inventory-6 (udi-6), incontinence impact questionnaire-7 (iiq-7), international consultation on incontinence questionnaire urinary incontinence short form (iciq-ui sf) as well as a satisfaction with treatment visual analog scale (vas).

Eligibility criteria:
inclusion criteria: * informed consent form signed * oab/urgency incontinence of at least 3 months duration * conservative treatment (medicines, electrical stimulation) has been tried without sufficient benefit * there is indication for cystoscopic injection treatment with botox® * more than 3 months since any previous treatment with botox® * detrusor overactivity documented by cystometry is desirable, but not obligatory exclusion criteria: * age below 18 years * mixed incontinence with predominant stress component * insufficient understanding of norwegian and / or unable to fill out the necessary forms * ongoing urinary tract infection (uti) (defined as positive urine stix (nitrite and leucocytes) with symptoms of uti) must be treated before inclusion. * any contraindication stated in the summary of product characteristics (spc) for botox

Keywords: onabotulinum toxin a urinary bladder emda iontophoresis electrophoresis urinary incontinence
resistance to methotrexate in patients with acute lymphoblastic leukemia in relapse or remission

Conditions: Leukemia

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. purpose: this laboratory study is looking at resistance to methotrexate in patients with acute lymphoblastic leukemia in relapse or remission.

objectives: * determine the mechanisms of intrinsic and acquired methotrexate resistance using in vitro assays of matched initial diagnosis, relapsed, and nonrelapsed (control) leukemic blast samples from patients with acute lymphoblastic leukemia in relapse or remission. * determine if the mechanisms of acquired methotrexate resistance are related to dosage or timing of methotrexate administration or other clinical factors in these patients. outline: random samples of frozen leukemic blasts from relapsing patients at initial diagnosis and relapse are selected. a corresponding sample from nonrelapsing patients (control) at initial diagnosis is also randomly selected. reduced folate carrier (rfc) and dehydrofolate reductase (dhfr) expression is measured using a quantitative reverse transcriptase-polymerase chain reaction assay of prepared rna. dhfr gene amplification is measured by a dot blot analysis of prepared dna. results of these assays are used to determine if a particular mechanism of acquired methotrexate resistance is associated with a particular subset of acute lymphoblastic leukemia patients. data are collected regarding the actual timing and dosage of methotrexate received by each patient and are correlated with the mechanisms of resistance. projected accrual: a total of 135 paired samples will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * acute lymphoblastic leukemia (all) in relapse, including all risk groups and leukemia subtypes, with frozen leukemic blast samples stored from the time of initial diagnosis and relapse * non-relapsing all (as control) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: adult acute lymphoblastic leukemia in remission childhood acute lymphoblastic leukemia in remission recurrent adult acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia
prospective evaluation of patient reported xerostomia after whole brain radiation

Conditions: Xerostomia

Summary: the goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity.

the parotids have not been traditionally considered an organ at risk / avoidance structure in whole brain radiation. however, patients receiving whole brain radiation sometimes complain of dry mouth. investigators hypothesize that standard whole brain radiation fields cause an acute measurable increase in xerostomia at one month post-radiation, and that the severity of xerostomia is related to the dose received by the parotids. in this study, investigators will use the validated university of michigan xerostomia questionnaire to prospectively collect baseline and post-radiation xerostomia scores up to 6 months after treatment. the radiation dose to the parotids will be evaluated to assess whether there is a dose-toxicity relationship. investigators anticipate a total accrual of 60 patients with a goal of 48 evaluable patients.

Eligibility criteria:
inclusion criteria: * patients to be treated with whole brain radiation in 10-15 fractions to a total dose of 25-37.5 gy for a diagnosis of brain metastases from any disease site or as prophylaxis in the treatment of potentially subclinical intracranial disease (e.g. from small cell lung cancer). * has not had prior radiation that would have exposed the parotids to a significant (estimated \>10 gy mean parotid dose) level of radiation within the past one year. patients receiving prior stereotactic radiosurgery for brain metastasis are eligible for inclusion in this trial as this form of radiation is highly conformal and exposes the parotids to minimal (estimated \<1 gy) radiation. * greater than or equal to 18 years of age (no upper age limit). * informed consent obtained. exclusion criteria: * patients receiving whole brain radiation without the use of a ct-based planning simulation. * patients who are on medications known to cause dry mouth, such as anticholinergics. * physically unable to communicate by paper or phone to complete the study survey. * prisoners.
myo-inositol and vitamin d3 during ivf

Conditions: Female Infertility

Summary: administration of a multicomponent dietary supplement (myo-inositol, vitamin d3, folic acid and melatonin) to women undergoing ivf procedures. the aim of the study is to monitor the effects on the pregnancy, implantation and abortion rates.


Eligibility criteria:
inclusion criteria: * bmi (kg/m2): 18.5 - 24.9 * basal fsh on day 3 \<15 miu/ml exclusion criteria: * presence of insulin resistance (ir) * hyperglycaemia, hyperprolactinemia, hypothyroidism or androgen excess * diagnosis of pcos (according to rotterdam eshre-asrm sponsored pcos consensus workshop group) * intake of hormones or drugs that can potentially influence the ovulation * fsh\>15 on day 3